Staff Design Quality Engineer – Global Expansions

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the primary technical authority for design control, product risk management, and regulatory compliance across global markets.

• Facilitate regional customization, platform enhancement, and localization of both new and existing products.

• Incorporate local design specifications into the global product development process.

• Collaborate across various departments including Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance.

• Function as the Subject Matter Expert (SME) to ensure Design History Files align with compliance standards of target international markets.

• Lead quality evaluations on the effects of change controls, CAPAs, and nonconformances on the overall system.

• Act as the primary Quality liaison for regulatory agency inquiries related to global expansions.

• Assist with CAPA and complaint investigations.

• Identify, prioritize, communicate, and address quality issues.

⛳️ Requirements

• Demonstrated experience in Design Quality Engineering and Assurance within the medical device sector.

• At least 8+ years of experience in medical device development.

• Minimum of 5+ years leading and executing global expansions in medical device development.

• Generally requires a Bachelor’s degree in a technical field and 8–12 years of related experience, or a Master’s degree with 5–7 years of relevant industry experience, or a PhD with 2–4 years of experience.

• Familiarity with design control, product risk management, and regulatory compliance.

• Understanding of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, and ISO 14971.

• Strong ability to work collaboratively with cross-functional teams.

• Excellent interpersonal, written, and verbal communication skills.

• Self-driven with a collaborative, proactive, and responsible attitude.

• Willingness to travel: 5–15%.

🏝️ Benefits

• A comprehensive and robust benefits package.

• Opportunities for growth on a global scale.

• Career advancement through in-house training programs and/or eligible tuition reimbursement.

• Home office work arrangements.

• Flexible workplace options may be available for employees within commuting distance of a Dexcom location.